Formulations of haloalkylamines and local anesthetic and methods

Details Formulations of haloalkylamines and local anesthetic and methods Formulations of haloalkylamines and local anesthetic and methods

1996-10-22

1999-04-27

Spivack, Phyllis G.

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Nitrogen containing other than solely as a nitrogen in an...

514537, 514651, 514655, A61K 31135, A61K 31165, A61K 3124

Patent

active

058980350

DESCRIPTION:

BRIEF SUMMARY
FIELD OF THE INVENTION

The invention pertains to the field of pain management in medicine. More specifically, the invention pertains to the field of managing and treating the pain and other symptoms resulting from the disorder known as reflex sympathetic dystrophy (RSD).


BACKGROUND ART

Reflex Sympathetic Dystrophy, or "RSD," is a common but poorly recognized chronic syndrome that most often occurs following traumatic injury to a limb. It is also associated with heart attack (myocardial infarction) and certain disorders of the nervous system. RSD includes disorders that were in the past known as causalgia, minor causalgia, post-traumatic pain syndrome, post-traumatic spreading neuralgia, post-traumatic vasomotor disorders, post-traumatic painful arthrosis, Sudeck's atrophy, sympathalgia, shoulder-hand syndrome, chronic traumatic edema, post-traumatic edema, autonomic hyper-reflexia, and reflex dystrophy, among others. (See: Bonica, J. J., The Management of Pain, Second Ed., Lea & Febiger, Philadelphia, 1990, pp. 220-243). The International Association for the Study of Pain continues to distinguish "causalgia," which is a more severe disorder often caused by nerve injury from war-inflicted shrapnel or projectile wounds, and which has some distinctive symptoms such as psychological disturbances that apparently result from the continuous, intense pain. However, most clinicians and researchers recognize that causalgia is symptomologically quite similar to the reflex sympathetic dystrophies, that it is treated in essentially the same way, and that it likely results from the same underlying mechanisms. Therefore, we hereinafter use the terms reflex sympathetic dystrophy and "RSD" to mean all of the above-mentioned disorders, including causalgia, as well as other disorders that fall within the symptomological definition of RSD.
RSD causes pain, stiffness, disturbances of the limb's blood vessels and muscles, and swelling. It is generally disabling because of the intensity of the pain. Also, since movement of the affected limb makes the pain much worse, patients suffering from RSD often stop using the affected limb at all. (Lankford, L. L., Reflex Sympathetic Dystrophy, in: Management of Peripheral Nerve Problems, G. E. Omer, Jr., and M. Spinner, eds; W. B. Saunders Co., Philadelphia, 1980; pp. 216-244.)
RSD often occurs following sprains, dislocations, and fractures of the hands, feet or wrists, and also following traumatic amputation of fingers, hands or wrists. However, the likelihood of developing RSD and its severity cannot be predicted based upon the severity of the injury; the disorder can even be caused by seemingly minor injuries such as contusions, cuts or even pinpricks to the fingers, hands, toes or feet. Following heart attacks, some patients develop a form of RSD known as "shoulder-hand syndrome," where the shoulder becomes painful and disabled, and the hand on the same side becomes painful and swollen.
Although many theories have been advanced, the mechanism that causes RSD is not clearly understood. One recent view is that RSD is caused by increased firing of peripheral nerves due to increased sensitivity, which in turn causes altered responses by the spinal cord, which then responds abnormally to signals from the brain stem and cortex. (See: Schwartzman, R. J. and T. L. McLellan, Reflex Sympathetic Dystrophy, Arch. Neurol. 44:555-561).
Unless successfully treated, RSD progresses through three stages of increasing disability. In Stage I, the "acute" phase, there is a burning or aching pain that is greater than the pain caused by the initial injury. The pain gets worse when the limb is touched, or when the patient becomes emotionally upset. The limb becomes swollen, hot or cold to the touch, and there is pronounced hair and nails growth. In Stage II, the "dystrophic" phase, the limb becomes hard and swollen, sweaty, and cool, and the hair begins to fall out. The nails become ridged, cracked and brittle. The pain becomes constant, and is increased by any stimulation of the limb. In Stage III, the

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